The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.

Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24 [ Time Frame: From start of study treatment to Week 24 ] [ Designated as safety issue: No ]

The proportion of participants with virologic failure (see primary outcome measure for definition) and/or premature treatment discontinuation/modification and/or death was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.

Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment [ Time Frame: From start of study treatment to week 52 ] [ Designated as safety issue: Yes ]

Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Results report the percentage of participants who had grade 3 or higher events, or events of any grade which led to a permanent change or discontinuation of study treatment, which occurred any time from start of treatment to end of treatment.

Number of Participants With Pretreatment Drug Resistance [ Time Frame: At screening ] [ Designated as safety issue: No ]

Results report the number of participants who had resistance to non-nucleoside reverse transciptase inhibitors (NNRTI), nucleoside reverse transciptase inhibitors (NRTI) and protease inbitors (PI) based on genotypic resistance testing done prior to participant's entry into the study. Participants are classified into one (and only one category) based on the maximum number of drug class resistance seen for the participant.

Number of Participants With Integrase Drug Resistance at Virologic Failure [ Time Frame: From 12 weeks after starting study treatment to week 52 ] [ Designated as safety issue: No ]

Results report the number of participants who had integrase resistance mutation(s) detected at the time of virologic failure.

Number of Participants With Protease Drug Resistance at Virologic Failure [ Time Frame: From 12 weeks after starting study treatment to week 52 ] [ Designated as safety issue: No ]

Results report the number of participants who had protease resistance mutation(s) detected at the time of virologic failure.

Number of Participants With Perfect Overall Adherence by Self Report [ Time Frame: From one week after starting study treatment to week 52 ] [ Designated as safety issue: No ]

At each study visit, adherence was measured in terms of the number of missed doses each participant had over a 4-day recall for each drug. Adherence for all study visit weeks were combined for an overall measure of adherence. Participants who had zero missed doses on all weeks in all drugs while on study were classified as having an overall "perfect" adherence.

Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24 [ Time Frame: From start of study treatment through week 24 ] [ Designated as safety issue: No ]

Plasma trough concentrations (ng/ml) of Raltegravir (RAL) below the detection limit (10 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 9-15 hours after the last RAL dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.

Plasma trough concentrations (ng/ml) of Darunavir (DRV) below the detection limit (50 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 20-28 hours after the last DRV dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.

Despite the remarkable strides made in the treatment of HIV-1-infected persons over the last decade, current first-line ART regimens are imperfect. The ideal combination, unlike some current first-line options, would have uncompromised efficacy in the presence of transmitted drug-resistant variants. The primary purpose of this study is to estimate the cumulative proportion of ART-naive participants experiencing virologic failure at or prior to week 24 after initiating raltegravir (RAL) plus darunavir/ritonavir (DRV/RTV).

The study will last 52 weeks. All participants will follow the same treatment schedule and take RAL plus DRV/RTV orally daily for the duration of the trial.

After entry, all participants will have scheduled visits at weeks 1, 4, 12, 24, 36, 48, and 52. Medical/medication history, blood and urine collection, and liver function tests will occur at screening. A targeted physical exam and concomitant medications history will occur at all study visits. Blood and urine collection and liver function tests will occur at most study visits. For females, a pregnancy test will occur at screening and study entry.

RAL and DRV were provided by the study. RTV was not provided by the study.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

HIV-1-infected

Plasma HIV-1 RNA of at least 5,000 copies/mL within 90 days prior to study entry

HIV genotype (for reverse transcriptase and protease) performed at any time prior to study entry. More information on this criterion can be found in the protocol.

ARV drug-naive. More information on this criterion can be found in the protocol.

Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry

Agree to use one form of medically-accepted contraceptive throughout the study and for 60 days after stopping study treatment. More information on this criterion can be found in the protocol.

Exclusion Criteria:

Serious illness requiring systemic treatment and/or hospitalization for at least 7 days prior to study. More information on this criterion can be found in the protocol.

Treatment with immunomodulators within 30 days prior to study entry. More information on this criterion can be found in the protocol.

Current medications that are prohibited with any study medications. More information on this criterion can be found in the protocol.

Known allergy/sensitivity to study drugs or their formulations. A history of sulfa allergy is not an exclusion.

Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with the study.

Certain abnormal laboratory results. More information on this criterion can be found in the protocol.

Pregnant or breastfeeding

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830804